Application Engineer
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Immediate need for a talented Application Engineer. This is a 06+months contract opportunity with long-term potential and is located in San Bruno, CA(Hybrid). Please review the job description below and contact me ASAP if you are interested.
Job ID: 24-40241
Pay Range: $85 - $95/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- As a Software Quality Engineer , you will work with the software organization to act as a champion of Quality Assurance and Engineering activities throughout the software development lifecycle.
- You hold your work and teams to the highest quality standards and ensure that all corporate business requirements, regulations, and other standards are met, as applicable.
- This is a hands-on role where you will apply intensive, self-directed and diversified knowledge of engineering and quality principles for software and platforms.
- This contract position offers an opportunity to contribute to the enhancement and maintenance of digital health solutions that directly impact patient care and well-being.
Key Requirements and Technology Experience:
- Key skills; Standalone Software as a Medical Device (SaMD) 3-5 years recent
- Quality management systems (QMS)
- Should be a Quality Engineer/Design Assurance Engineer in recent 3-5 years no managerial experience required
- Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, as well as SDLC processes and tool initiatives, through the integration of internal and external/medical device industry best practices.
- Support software development teams in the creation of Design History Files (DHFs) including software development plans, software verification and validation plans, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports and traceability matrices.
- Support integration of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes.
- Guide software development teams in design controls and risk management activities.
- Foster organizational compliance to the quality system including ongoing training and education on software QMS and SDLC framework. Provide CAPA, complaints, audit and overall QMS support in regards to software.
Our client is a leading IT Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
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